Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review
2. Materials and Methods
2.1. Search Strategy
2.2. Selection Criteria
- provided guidance on conducting clinical research during the COVID-19 pandemic;
- were authored by a body (e.g., organisation, governing body, institution) based in a member country of the OECD;
- were available in English; and
- were published online.
2.3. Data Extraction
3.1. Search Results and Included Studies
3.2. General Characteristics
3.3. Findings from Publications That Developed Recommendations (n = 33)
3.5. Risk-Benefit Assessment and Contingency Measures
3.6. COVID-19 Symptom Screening
3.7. Continuation of Clinical Research
3.8. Recruitment of Participants
3.9. Remote Source Data Verification
3.10. Use of Information Technology (IT)
3.11. Delivery and Administration of Invetigational Medicinal Product (IMP)
3.12. Ethical Considerations and Informed Consent
3.13. Findings from Publications Endorsing Other Recommendations
3.14. Quality of Included Guidance
4.1. Differences in Guidance Based on Date Published
4.2. Limited Discussion of PPE
4.3. Principles to Be Carried Forward and Potential Long-Term Impact of Recommendations
4.4. Strengths and Limitations of the Review
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
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|Abbreviation of Publishing Body||Country of Origin||Date of Publication/Update||Monitoring||Risk-Benefit Assessment and Contingency Measures||COVID-19 Symptom Screening||Continuation of Trials||Recruitment of Participants||Remote Source Data Verification||Information Technology||Delivery of IMP to Participant Home||Informed Consent|
|NHMRC * ||AUSTRALIA||9 April 2020||✓||✓||N/R||✓||✓||✓||✓||✓||N/R|
|QLD GOV ||AUSTRALIA||7 April 2020||✓||✓||✓||✓||N/R||N/R||✓||✓||N/R|
|RMH ||AUSTRALIA||13 May 2020||X||✓||✓||N/R||N/R||N/R||✓||N/R||N/R|
|MA ** ||AUSTRALIA||23 March 2020||✓||N/R||N/R||N/R||✓||N/R||✓||✓||N/R|
|BCAHSN ||CANADA||March 2020||X||✓||N/R||N/R||N/R||N/R||N/R||N/R||✓|
|CA GOV ||CANADA||Updated 6 May 2021||✓||✓||✓||N/R||✓||N/R||✓||✓||✓|
|INVIMA ||COLOMBIA||17 March 2020||✓||✓||N/R||✓||✓||N/R||✓||✓||N/R|
|SUKL ||CZECH REPUBLIC||22 December 2020||✓||N/R||✓||✓||✓||N/R||✓||✓||✓|
|DKMA ||DENMARK||13 March 2020||✓||✓||N/R||✓||✓||✓||✓||✓||N/R|
|SAM ||ESTONIA||18 March 2020||✓||✓||N/R||N/R||✓||X||✓||✓||N/R|
|EMA ||EUROPEAN UNION||25 March 2020||✓||✓||N/R||✓||✓||✓||✓||✓||✓|
|EMA ||EUROPEAN UNION||25 March 2020||✓||✓||✓||✓||✓||N/R||N/R||N/R||N/R|
|FIMEA ||FINLAND||19 March 2020||✓||N/R||N/R||N/R||N/R||N/R||✓||✓||N/R|
|ANSM ||FRANCE||21 October 2020||✓||✓||N/R||✓||N/R||N/R||✓||✓||N/R|
|OECD ||INTERNATIONAL ORGANISATION||4 August 2020||N/R||N/R||N/R||N/R||N/R||N/R||✓||✓||N/R|
|BfArM ||GERMANY||30 March 2020||N/R||N/R||N/R||N/R||X||N/R||✓||N/R||N/R|
|OGYI ||HUNGARY||25 March 2020||N/R||✓||N/R||N/R||X||N/R||✓||✓||✓|
|HPRA ||IRELAND||13 March 2020||✓||✓||N/R||N/R||X||N/R||✓||✓||✓|
|AIFA ||ITALY||7 April 2020||N/R||✓||N/R||✓||N/R||N/R||✓||✓||✓|
|ZVA ||LATVIA||17 March 2020||N/R||N/R||N/R||✓||✓||N/R||✓||✓||N/R|
|CCMO ||NETHERLANDS||23 February 2021||N/R||N/R||N/R||✓||✓||X||✓||✓||✓|
|IGJ ||NETHERLANDS||8 April 2020||✓||N/R||N/R||✓||N/R||X||N/R||✓||✓|
|NOMA ||NORWAY||16 March 2020||✓||N/R||N/R||N/R||✓||X||✓||✓||✓|
|AEMPS ||SPAIN||27 April 2020||✓||✓||N/R||N/R||✓||N/R||✓||✓||✓|
|MPA ||SWEDEN||18 December 2020||✓||✓||N/R||N/R||N/R||✓||✓||✓||N/R|
|SM ||SWITZERLAND||17 December 2020||N/R||✓||N/R||✓||✓||✓||✓||✓||✓|
|MHRA [35,36]||UK||19 March 2020||✓||✓||N/R||✓||✓||N/R||✓||✓||N/R|
|NHS ||UK||12 March 2020||✓||N/R||✓||✓||✓||✓||✓||N/R||✓|
|CTTI ||USA||13 April 2020||N/R||✓||✓||✓||✓||N/R||✓||✓||✓|
|FDA ||USA||18 March 2020||✓||✓||N/R||N/R||N/R||N/R||✓||✓||✓|
|IOSIBD ||USA||10 June 2020||N/R||N/R||✓||✓||✓||N/R||✓||✓||N/R|
|PAHO ||USA||5 June 2020||✓||N/R||N/R||✓||N/R||N/R||✓||N/R||N/R|
|ASCO ||USA||12 May 2020||N/R||N/R||N/R||N/R||N/R||N/R||✓||✓||N/R|
|Country||Name of Document/Website||Body||Endorsed Recommendation|
|1||Australia||COVID-19: Guidance on Australian clinical trials for institutions, HRECs, researchers and sponsors ||ACTA||NHMRC|
|2||Australia||Clinical Trial Processes ||TGA||NHMRC|
|3||Australia||COVID-19 clinical trial guidance ||NSW Health||NHMRC|
|4||Australia||Clinical trial conduct during the COVID-19 pandemic ||CTIQ||NHMRC|
|5||Belgium||Responsibility of Research Ethics Committees during the COVID-19 Pandemic ||EUREC||EMA|
|6||Canada||Guidance during COVID-19 Outbreak ||HREBA||FDA|
|7||Canada||Health Canada Notice: Management of clinical trials during COVID-19 ||CAPRA||Health Canada|
|8||Canada||Regulations, guidelines, important links: Quality assurance for clinical trials ||UCAL||FDA|
|9||Canada||Clinical trials or studies involving a drug, medical device, or natural health product ||UWaterloo||Health Canada|
|10||Canada||COVID-19 Resources: Clinical trials and research involving humans ||CIHR||Health Canada|
|11||Canada||COVID-19 Regulatory Updates for the Clinical Trials Community ||CTO||Health Canada|
|12||New Zealand||COVID-19 Resources for Researchers ||HSRI||NHMRC|
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Bhutkar, R.; Collins, J.C.; O’Reilly, C.L.; El-Den, S. Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review. Pharmacy 2023, 11, 15. https://doi.org/10.3390/pharmacy11010015
Bhutkar R, Collins JC, O’Reilly CL, El-Den S. Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review. Pharmacy. 2023; 11(1):15. https://doi.org/10.3390/pharmacy11010015Chicago/Turabian Style
Bhutkar, Renu, Jack C. Collins, Claire L. O’Reilly, and Sarira El-Den. 2023. "Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review" Pharmacy 11, no. 1: 15. https://doi.org/10.3390/pharmacy11010015